Myovant hits goal in uterine fibroid phase 3, teeing up AbbVie showdown

A phase 3 trial of Myovant Sciences' uterine fibroid drug relugolix has hit its primary endpoint, moving the Roivant unit a step closer to a planned filing for approval. The drug comfortably beat placebo against a slew of efficacy endpoints and posted comparable safety and tolerability to the control. Myovant, part of Roivant’s stable of biotechs, picked up the global rights to relugolix from Takeda Pharmaceutical in 2016 and moved it into a pair of phase 3 trials the following year. Results from the first trial are in. The study enrolled 388 women with uterine fibroids and heavy menstrual bleeding. Among subjects randomized to receive relugolix on top of estradiol and norethindrone acetate for 24 weeks, 73.4% achieved the responder criteria, which looked at change in blood loss. In the placebo arm, 18.9% of women met the criteria, resulting in a primary endpoint success with a p-value of less than 0.0001.